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单克隆抗体药代动力学药效学模型研究进展
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引用本文:何华,张雪,王玉浩,柳晓泉.单克隆抗体药代动力学药效学模型研究进展[J].中国药科大学学报,2015,46(3):279-288.
Cite:HE Hua,ZHANG Xue,WANG Yuhao,LIU Xiaoquan.Advances in pharmacokinetic and pharmacodynamic modeling of monoclonal antibody[J].J China Pharm Univ,2015,46(3):279-288.
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作者单位
何华 中国药科大学药物代谢动力学研究中心 
张雪 中国药科大学药物代谢动力学研究中心 
王玉浩 中国药科大学药物代谢动力学研究中心 
柳晓泉 中国药科大学药物代谢动力学研究中心 
中文摘要:治疗性单克隆抗体是目前新药研发的一个热点。和小分子药物相比,单克隆抗体药物相对分子质量大,与靶点的结合具有更高的特异性和选择性。用于描述其药代动力学(PK)和药效学(PD)行为的PK模型和PK/PD模型也有了新的发展。本文从吸收、分布、消除等方面综述了单克隆抗体药物的PK特征,对当前用于该类药物PK研究的靶点介导药物处置(TMDD)模型和生理药代动力学模型(PBPK)进行了介绍,并基于药物与靶点作用的4类应用(免疫毒性治疗、靶细胞消除、改变细胞功能和靶向给药)分别介绍了单克隆抗体药物的PK/PD模型。
中文关键词:单克隆抗体  药代动力学  药效学  模型  靶向给药  抗体偶联药物
 
Advances in pharmacokinetic and pharmacodynamic modeling of monoclonal antibody
Abstract:The successes of therapeutic monoclonal antibodies(mAbs)in clinical practice has drawn more attention to mAbs development. Compared to chemical drugs with small molecules, mAbs have larger molecular weight; besides, they show much higher selectivity and specificity. As a result, new pharmacokinetic(PK)and pharmacokinetic/pharmacodynamic(PK/PD)models have been proposed to guide mAbs development. This article summarizes the unique PK characteristics of mAbs and introduces the models used in PK investigation of mAbs, such as target-mediated drug disposition(TMDD)model and physiologically based pharmacokinetic(PBPK)model. In addition, four different categories of PK/PD models for mAbs in immuno-toxicotherapy, target-cell elimination, alteration of cellular function and drug targeting are also reviewed in the present article.
keywords:monoclonal antibody  pharmacokinetics  pharmacodynamics  model  targeted drug delivery  antibody drug conjugates
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